01 1LABORATORI ALCHEMIA SRL
02 1Osaka Synthetic Organic Chemistry Laboratory Co., Ltd.
03 1Procos S. p. A.
04 1Shiono Finesse Co., Ltd.
01 1Japanese Pharmacopoeia Sivelestat sodium hydrate production-only
02 2Sivelestat sodium hydrate
03 1Sivelestat sodium hydrate "SFL"
01 2Italy
02 2Japan
Registration Number : 225MF10154
Registrant's Address : Via San Faustino, 68 20134 MILANO-Italy
Initial Date of Registration : 2013-08-09
Latest Date of Registration : 2013-08-09
Japanese Pharmacopoeia Sivelestat Sodium Hydrate For manufacturing purposes only
Registration Number : 226MF10229
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2014-12-08
Latest Date of Registration : 2014-12-08
Registration Number : 225MF10161
Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY
Initial Date of Registration : 2013-08-14
Latest Date of Registration : 2013-08-14
Sivelestat sodium hydrate "SFL"
Registration Number : 218MF10428
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 3-1-6
Initial Date of Registration : 2006-04-27
Latest Date of Registration : 2014-05-29
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
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